(65 days)
Not Found
No
The document describes a mechanical device (balloon catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in arteries and dialysis fistulae, which is a therapeutic intervention.
No
The device is a therapeutic device (a balloon dilatation catheter) used for Percutaneous Transluminal Angioplasty (PTA), not a diagnostic one. Its purpose is to treat obstructive lesions, not to diagnose them.
No
The device description clearly details a physical catheter with a balloon, lumens, and radio-opaque markers, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a catheter used for Percutaneous Transluminal Angioplasty (PTA). This is a procedure performed inside the body to widen narrowed or blocked blood vessels. It is a therapeutic device, not a diagnostic one that analyzes samples.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is to physically dilate blood vessels.
Therefore, based on the provided information, the Vector™ PTA Balloon Dilatation Catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Vector™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the teatment of obstructive or synthetic arterio-venous dialysis fistulae.
The Vector Catheter is not indicated for use in the coronary arteries or for placement of or post dilation of stents.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
The Vector™ PTA Balloon Dilatation Catheter is a high pressure, non-compliant balloon catheter. It is a coaxial dual lumen over-the-wire balloon dilatation catheter. The central lumen accommodates guide wires up to the 0.035 inches in diameter while the outer lumen is the inflation lumen for the balloon.
The balloon is a high pressure composite balloon with radio-opaque marker bands to help visualize the balloon placement within the vasculature during both placement and inflation. The balloon's rated burst pressure is 30 atm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, iliac, popliteal, and renal arteries; arterio-venous dialysis fistulae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on the risk analysis of the modified device, and testing was conducted on the modified Vector™ PTA Balloon Dilatation Catheter. The testing performed on the modified devices was:
Rated Burst Pressure, Balloon Compliance, Balloon Diameter Sizing, Inflation/deflation times. Repeat Inflation. Removal/Refold & Reuse. Flexibility / Kink, Crossing Profile, Balloon Protector Removal, Guide wire/Introducer Compatibility, Tensile Strength, Visibility under Fluoro-imaging, Torque Strength and Catheter Leak.
All devices met the performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The profiles are facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2015
Vector Corporation LLC c/o Ms. Laurie Lewandowski Honkanen Consulting, Inc. 738 Saddle Wood Drive Eagan, MN 55123
Re: K143652
Trade/Device Name: Vector PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: January 30, 2015 Received: February 2, 2015
Dear Ms. Lewandowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143652
Device Name
Vector™ PTA Balloon Dilatation Catheter
Indications for Use (Describe)
The Vector™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the teatment of obstructive or synthetic arterio-venous dialysis fistulae.
The Vector Catheter is not indicated for use in the coronary arteries or for placement of or post dilation of stents.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
l Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
Vector Corporation
Primary Contact Person
Laurie Lewandowski, Consultant Honkanen Consulting, Inc. 738 Saddle Wood Drive Eagan, MN 55123 Phone: 612-770-4038 Email: lalew207@gmail.com
Sponsor's Contact
Jay Sturm Vector Corporation LLC 1270 Ave of Americas. Suite 302 New York, NY 10020 Phone: 646-833-3700 Email: jsturm(a)volcanocap.com
Device Name
Trade Name: Vector™ Common Name: Percutaneous Catheter Classification Name: Percutaneous Catheter Classification: II Product Code: LIT Regulation Number: 21 CFR 870.1250
Predicate Device
The device is substantially equivalent to the r4 Vascular, Inc. Vector4™ PTA Balloon Dilatation Catheter (K131329).
Indications for Use/Intended Use
The Vector™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arterio-venous dialysis fistulae.
The Vector" Catheter is not indicated for use in the coronary arteries or for placement of or post dilatation of stents.
5
Device Description
The Vector™ PTA Balloon Dilatation Catheter is a high pressure, non-compliant balloon catheter. It is a coaxial dual lumen over-the-wire balloon dilatation catheter. The central lumen accommodates guide wires up to the 0.035 inches in diameter while the outer lumen is the inflation lumen for the balloon.
The balloon is a high pressure composite balloon with radio-opaque marker bands to help visualize the balloon placement within the vasculature during both placement and inflation. The balloon's rated burst pressure is 30 atm.
Technological Characteristics
The Vector™ PTA Balloon Dilatation Catheter was cleared under K131329. The fundamental scientific technology and technological characteristics for the Vector™ PTA Balloon Catheter remain the same as Vector4™ PTA Balloon Dilatation Catheter.
Vector™ is a coaxial dual lumen over-the-wire balloon dilatation catheter. The central lumen accommodates guide wires up to 0.035 inches in diameter while the outer lumen is the inflation lumen for the balloon. The catheter includes an atraumatic tip to ease advancement of the catheter to and through the stenosis.
The balloon is a high pressure, Parylene coated, composite balloon with marker bands located at the proximal and distal end of the balloon working length and at the distal tip to help visualize placement within the lesion or stenosis. The balloon's rated burst pressure is 30 atm.
The catheter is supplied sterile and non-pyrogenic. Different balloon sizes (5 mm to 10 mm) and catheter lengths (50 to 135 cm) are available. The proximal end of the catheter contains a hub with two female luer locks.
The device is compatible with 6-7F introducers. The introducer compatibility for each device size is listed on the device label. The materials used in the construction are biocompatible and not made with natural rubber latex.
The modifications to the Vector™ PTA Balloon Dilatation Catheter are as follows.
-
- Removal of radiopaque coating, BaSO4 tip doping and addition of marker bands
-
- Angled the balloon fibers and modified the fiber denier
-
- Updates to the IFU for company name, product name, use of contrast
-
- Increased flow for reduced inflation / deflation times
-
- Increased product robustness for balloon bonds and reduction in introducer withdrawal force
-
- The 6 Fr balloon protector ID was increased slightly.
There are no changes in the balloon catheter dimensions or significant changes in weight with these modifications.
6
Performance Data
Based on the risk analysis of the modified device, and testing was conducted on the modified Vector™ PTA Balloon Dilatation Catheter. The testing performed on the modified devices was:
Rated Burst Pressure, Balloon Compliance, Balloon Diameter Sizing, Inflation/deflation times. Repeat Inflation. Removal/Refold & Reuse. Flexibility / Kink, Crossing Profile, Balloon Protector Removal, Guide wire/Introducer Compatibility, Tensile Strength, Visibility under Fluoro-imaging, Torque Strength and Catheter Leak.
All devices met the performance specifications.
The device is sterilized by ethylene oxide to an SAL 10-6 level and the device is biocompatible meeting the requirements of ISO 10993-1.
The bench testing demonstrated that the device meets specifications indicating that the device is as safe and effective as the predicate device.
Substantial Equivalence
The modified Vector" PTA Balloon Catheter is substantially equivalent to the Vector4™ PTA catheter (K131329). They have the identical intended use, and treat the same target population. Both devices are intended to treat peripheral arteries. The manner in accessing and treating lesions in all these arteries is identical. The devices are similar in design with changes as described.
Conclusion
The modified Vector" PTA Balloon Catheters and the predicate Vector4™ PTA Balloon Catheters have identical intended use and similar technological characteristics and are therefore substantially equivalent. Bench testing of the Vector™ PTA Balloon Dilatation Catheters demonstrated that all product specifications were met. These tests demonstrate that the Vector" PTA Balloon Dilatation Catheters are as safe and effective as the predicate device.